Thoracic aorta stent graft with access region

ABSTRACT

A stent graft (2) for placement in the thoracic arch of a patient has a first tubular body portion (6) with a first lumen therein for placement in the ascending aorta of a patient and a second tubular body portion (8) to extend along the thoracic arch and down the descending aorta. The second tubular body portion is of a lesser diameter than the first tubular body portion. There is a step portion (10) between the first body portion and the second body portion. The step portion is joined to and continuous with the first portion and the second portion. A first side of each of the first body portion, the step portion and the second body portion are substantially aligned so that there is a step (18) defined on a second side opposite to the first side of the body portion. There is an aperture (30) in the step portion and an internal tube (32) extending from the aperture towards the first body portion. The internal tube is divided along part of its length into at least two smaller internal tubes (34, 36) with the smaller internal tubes opening into the first lumen.

The present patent document is a divisional application that claims thebenefit of priority under 35 U.S.C. § 121 of U.S. patent applicationSer. No. 14/793,004, filed Jul. 7, 2015, which is a continuationapplication that claims the benefit of priority under 35 U.S.C. § 120 ofU.S. patent application Ser. No. 13/061,065, filed Jul. 1, 2011, nowU.S. Pat. No. 9,101,456, which is a § 371 filing based on PCTApplication Serial No. PCT/US2009/004827, filed Aug. 25, 2009 (andpublished as WO 2010/024879A1 on Mar. 4, 2010), designating the UnitedStates and published in English, which claims the benefit of the filingdate under 35 U.S.C. § 119(e) of Provisional U.S. Patent ApplicationSer. No. 61/190,141, filed Aug. 26, 2008. All of the foregoingapplications are hereby incorporated by reference in their entirety.

TECHNICAL FIELD

This invention relates to a medical device for treatment of aortic archdisease and more particularly to a stent graft for deployment into thethoracic aorta of a patient for that purpose.

BACKGROUND ART

In recent years endovascular implantable devices have been developed fortreatment of aortic aneurysms. These devices are delivered to thetreatment site through the vascular system of the patient rather than byopen surgery. The devices include a tubular or cylindrical framework orscaffolding of one or more stents to which is secured a tubular shape ofgraft material such as woven Dacron, polyester polytetrafluoroethyleneor the like. The devices are initially reduced to a small diameter,placed into the leading or proximal end of a catheter delivery systemwhereafter the delivery system is inserted into the vascular system ofthe patient such as through a femoral incision. The leading end of thedelivery system is manoeuvred to the treatment site over a previouslypositioned guide wire. Through manipulation of a control system thatextends to the proximal end of the catheter from the distal end of thesystem outside the patient, the implantable device is deployed byholding the device at its location and withdrawing a surrounding sheath.The implantable device or stent graft can then self expand or beexpanded through the use of a balloon which is introduced with a stentgraft introduction device. The stent graft becomes anchored intoposition in healthy wall tissue of the aorta, by barbs for example. Thedelivery system is then removed leaving the inflatable device inposition to reverse an aneurysm in the aorta in a manner that channelsall blood flow through the stent graft so that no blood flow enters theaneurysm. As a result, not only does the aneurysm no longer continue togrow and possibly rupture but the aneurysm actually begins to shrink andcommonly disappears entirely.

For treatment of thoracic aortic aneurysms in particular it is necessaryto introduce the implantable device high up in the aorta and in a regionof the aorta which is curved and where there can be strong blood flow.

In the thoracic aorta there are major branch vessels, thebrachiocephalic, the left carotid and the left subclavian. For treatmentof an aneurysm in the region of the thoracic arch provision must be madefor blood supply to continue to these arteries. For this purposefenestrations are provided into the wall of a stent graft in thatregion. Access is generally obtained to these fenestrations, to deployside arms into the stent graft, via the left or right brachial arteriesor less commonly via the left or right carotid arteries. Once into thethoracic arch via such an artery the fenestration in the stent graftmust be catheterised. To simplify this, it is desirable to have someworking space in the outer side of the thoracic arch which is the regionthat the branch vessels enter the arch.

It is the object of this invention to provide an arrangement of stentgraft to overcome the above problem or to at least provide thepractitioner with a useful alternative.

Throughout this specification the term distal with respect to a portionof the aorta, a deployment device or a prosthesis such as a stent graftis intended to mean the end of the aorta, deployment device orprosthesis such as a stent graft further away in the direction of bloodflow from the heart and the term proximal is intended to mean theportion of the aorta, deployment device or end of the prosthesis nearerto the heart. For other lumens within the human or animal body the termscaudal and cranial respectively should be understood.

Throughout this discussion the term “stent graft” is intended to mean adevice which has a tubular body of biocompatible graft material and atleast one stent fastened to the tubular body to define a lumen throughthe stent graft. The stent graft may be bifurcated and havefenestrations, side arms or the like. Other arrangements of stent graftsare also within the scope of the invention.

DISCLOSURE OF THE INVENTION

According to a first aspect of the present invention, there is provideda stent graft for placement in the thoracic arch of a patient, the stentgraft comprising a first tubular body portion and a second tubular bodyportion, the second tubular body portion having a smaller diameter thanthe first tubular body portion, the second tubular body portion havingat least one aperture for receiving a side branch stent graft such thatwhen the stent graft is curved during deployment, the at least oneaperture is located on or adjacent the outside of the curve.

It will be seen that by this invention there is provided a stent graftfor placement in the thoracic arch of a patient. In use, the first bodyportion is placed in the ascending aorta of a patient and the secondbody portion extends around the thoracic arch and down the descendingaorta. The stent graft can be placed such that the portion of the graftwhere the diameter starts to reduce is just proximal of thebrachiocephalic artery and on the outside of the curve of the thoracicarch. By this placement there is defined, by the difference in diameterof the first and second portions, an open region outside the stentgraft. This open region is distal of the aperture in the second portion,so that blood flow can occur through the aperture to the open regionenabling circulation to be preserved to the major vessels through theinternal branches during the progress of an operation. As the moredistal second portion of the stent graft is of a lesser diameter thereis provided a working space in which a guide wire from the brancharteries can be directed to enter the aperture to enablecatheterisation. Subsequently a side branch stent graft can be deployedfrom the respective branch artery into the stent graft to provide bloodflow into that branch artery.

In one example, a stent graft with a single aperture in the region ofreduced diameter could take a leg extension for one great artery withsurgical bypasses to the other arteries. The aperture (or fenestration)may be in a leading face of the reduced diameter region or hollow.

The stent graft may further comprise an internal tube extending from theaperture towards the first body portion.

The internal tube may be divided along at least part of its length intoat least two smaller internal tubes opening into the lumen of the firstbody portion.

The two discrete tubes allow leg extensions for two great arteries.

The internal tube may be divided along part of its length into threesmaller internal tubes which open into the lumen of the first bodyportion.

During an operation, this arrangement permits a working space in which aguide wire from one of the branch arteries can be directed to enter theinternal tube and subsequently one of the smaller internal tubes toenable catheterisation.

In a further aspect of the present invention, there is provided a stentgraft for placement in the thoracic arch of a patient, the stent graftcomprising a first tubular body portion with a first lumen therein forplacement in the ascending aorta of a patient and a second tubular bodyportion to extend around the thoracic arch and down the descendingaorta, the second tubular body portion being of a lesser diameter thanthe first tubular body portion, a step portion between the first bodyportion and the second body portion, the step portion being joined toand continuous with the first portion and the second portion, a firstside of the first body portion, a first side of the step portion and afirst side the second body portion being substantially aligned such thata step is defined on a second side opposite to the first side of thebody portion, an aperture in the step portion and an internal tubeextending from the aperture towards the first body portion, the internaltube being divided along part of its length into at least two smallerinternal tubes, the at least two smaller internal tubes opening into thefirst lumen.

At least one of the first tubular body portion and the second tubularbody portion comprise stents therealong. Preferably each of the tubularbody portions comprise stents therealong. Preferably the stents compriseself expanding stents for example zig zag self expanding stents. Theplurality of self expanding stents can be spaced apart longitudinally bysubstantially the axial length of adjacent stents to allow forflexibility of the stent graft. The graft material between the stentscan be corrugated to allow for flexibility of the stent graft.

The stent graft can be formed into a pre-curved shape longitudinallydefined by an inside curved side and an outside curved side and suchthat the second side is on the outside curved side. In this case, theaperture in the step portion is on the outside of the curve.

In a preferred embodiment, the aperture in the step portion or reduceddiameter region can be placed to one side of the outside of the curve.In this case, the aperture is adjacent or offset from the outside of thecurve.

Typically, the first tubular body portion can have a diameter of from 35to 50 mm. The second tubular body portion can have a diameter of from 20to 30 mm. The step portion can have a width of from 10 to 30 mm. Theinternal tube can be substantially circular or oval in cross section.The internal tube may have a diameter of from 15 to 20 mm. Where thereare two smaller internal tubes the two smaller internal tubes can havediameters of 10 mm and 12 mm respectively in one example.

Preferably there are two smaller internal tubes. There may be threesmaller internal tubes, one for each of the great vessels of thethoracic arch.

In a further embodiment the smaller internal tubes each have a diameterin the range of from 6 to 10 mm. In an alternative embodiment one of thetwo smaller internal tubes has a diameter in the range of from 6 to 8 mmand the other of the two smaller internal tubes has a diameter in therange of from 8 to 12 mm. In such a situation the larger of the twosmaller internal tubes is preferably adjacent the wall of the firstportion.

According to a further aspect of the invention, there is provided amethod of treatment of aortic aneurysm comprising deploying a stentgraft as claimed in any of claims 1 to 28 into the thoracic arch suchthat the aperture is placed just proximal of the junction of the aortawith the brachiocephalic artery.

According to a further aspect of the invention, there is provided amethod of treatment of aortic aneurysm comprising deploying a stentgraft as claimed in of claims 2 to 28 into the thoracic arch such thatthe step portion is just proximal of the junction of the aorta with thebrachiocephalic artery.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will now be described withreference to the accompanying drawings.

FIG. 1 shows a side view of a first embodiment of stent graft accordingto the present invention;

FIG. 2 shows a longitudinal cross sectional view of the embodiment shownin FIG. 1;

FIG. 3A shows a view from the proximal end of the embodiment shown inFIG. 1;

FIG. 3B shows a view from the proximal end of an alternative embodimentof the invention;

FIG. 4A shows a view from the distal end of the embodiment shown in FIG.3A;

FIG. 4B shows a view from the distal end of the embodiment shown in FIG.1;

FIG. 5 shows an alternative embodiment of stent graft according to thepresent invention;

FIG. 6 shows a longitudinal cross sectional view of the embodiment shownin FIG. 5;

FIG. 7 shows a view from the proximal end of the embodiment shown inFIG. 1; and

FIG. 8 shows a schematic view of the placement of a stent graftaccording to the present invention into the thoracic arch of a patient.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Now looking more closely at the drawings and more particularly theembodiment shown in FIGS. 1 to 4 it will be seen that the stent graft 2comprises generally a tubular body 4 of a biocompatible graft materialsuch as Dacron. The tubular body can be considered as comprising threemain portions, a first portion 6, a second portion 8 and a step portion10 between the first portion and the second portion. The first portion 6is of a diameter to fit into and engage the walls of the ascending aortaof a patient. The first portion may have a diameter of from 35 to 50 mm.The second portion 8 is of a lesser diameter than the first portion by 5to 15 mm. The length of the first portion may be from 20 to 60 mm, thelength of the second portion may be from 80 to 150 mm and the stepportion may have a length of from 10 to 30 mm. The step portion 10comprises a substantially straight inner side 12 aligned with innersides 14 and 16 of the first and second portions respectively. The stepportion 10 comprises an angled or tapered outer side 18 which extendsfrom the outer side 20 of the first portion to the outside 22 of thesecond portion.

A plurality of zig-zag stents 24 provide support for the tubular bodyalong the length thereof. At the proximal end 26 of the stent graft thezig-zag stent 24 a is on the inside to provide a smooth outer sealingsurface to engage against the wall of the ascending aorta. Particularlyin the second portion 8 the stents are spaced apart to enableflexibility of the stent graft to conform to the shape of the thoracicarch and the descending aorta. The stents in this region may be spacedapart by substantially the axial length of adjacent stents. In thisembodiment the graft material in the spaces between the stents is formedinto a corrugated structure 28 to give good flexibility between thestents as well as providing structural rigidity. The graft material inthe spaces between the stents can be reinforced with a helicalreinforcement wire. Helical reinforcement for graft material is shown inU.S. patent application Ser. No. 12/261,860 entitled “Flexible StentGraft” and the teachings therein are incorporated herein in theirentirety.

In the step portion 10 an aperture 30 is formed with an internal tube 32extending from the aperture towards the proximal end 26 of the stentgraft. A short distance within the recess from the aperture the internaltube divides into two smaller tubes 34 and 36 which again extend fromthe internal tube 32 towards the proximal end 26 of the stent graft.

In use when the stent graft is placed into the thoracic arch of apatient the step portion is positioned just proximal of thebrachiocephalic artery and on the outside of the curve of the thoracicarch. The first portion 6 extends proximally into the ascending aortaand the second portion 8 extending distally into the descending aorta.There is defined, by the difference in diameter of the first and secondportions, an open region defined between the stent graft and the outerside of the thoracic arch distal of the aperture in the step portion 10,so that circulation is preserved to the major vessels through theinternal branches during the progress of an operation. As the moredistal second portion of the stent graft is of a lesser diameter theopen region provides a working space in which a guide wire from themajor branch arteries can be manipulated to be directed to enter theaperture 30 and the internal tube 32 and subsequently one of the smallerinternal tubes 34 and 36 to enable catheterisation. Subsequently a sidebranch stent graft can be deployed from the respective branch arteryinto one of the smaller tubes to provide blood flow into that branchartery.

As can be seen in FIG. 3A which is a view from the proximal end 26 ofthe stent graft the smaller tubes 34 and 36 have their proximal endsformed into opposed D shapes and the uprights of each of the D′s arejoined to each other 38 to ensure that there are no dead zones in thestent graft in use. The smaller tubes 34 and 36 are also joined to theside wall of the first portion at 40. FIG. 4A shows the stent graft fromthe distal end. It can be particularly seen that the internal tube 32reduces to two smaller tubes 34 and 36.

Each of the smaller tubes 34 and 36 are also supported along theirlength with a zig-zag stent 42 and are reinforced at their proximal endswith a reinforcing ring 44.

FIGS. 3B and 4B show views from the proximal end and distal endrespectively of an alternative embodiment of the invention. In thisembodiment there are three smaller internal tubes 34, 35, 36 extendingfrom the internal tube 32 and directed towards the proximal end of thestent graft. Each of the brachiocephalic, the left carotid and the leftsubclavian can be connected to one of the smaller tubes via respectivebranch grafts.

FIGS. 5 to 7 show an alternative embodiment of stent graft according tothe present invention. In this embodiment the tubular body 52 of thisembodiment of stent graft 50 comprises a first portion 54, a stepportion 56 and a second portion 58. The first portion 54 comprises atubular body of a biocompatible graft material and is supported by selfexpanding zig-zag stents 60. The stent 60 a at the proximal end isinternal to provide a smooth sealing surface to engage against the wallof the ascending aorta and the stent 60 b is external. The first portionmay have a diameter of from 35 to 50 mm.

The second portion 58 is again formed from a tubular body of abiocompatible graft material and is supported by self expanding zig-zagstents 68. The tubular body of the second portion is formed into apartly curved shape by a greater distance between the stents 68 on theoutside of the curve 69 than the inside of the curve 70. The secondportion 58 can have a diameter in the range of from 30 to 40 mm. Thestep portion 56 is again formed from a frusto-conical tubular body of abiocompatible graft material and is supported by self expanding zig-zagstents 64 and 66. The step portion has a diameter at its proximal end 67which is substantially the same as the diameter of the first portion anda diameter at its distal end which is substantially the same as thediameter of the second portion. The step portion has all of its taperbetween the diameter of the first portion and the diameter of the secondportion on the outside 72 of the curve of the stent graft.

As can be particularly seen in FIG. 5 the step portion 56 has anaperture or fenestration 74 which opens into a recess 76 within the stepportion and the recess extends proximally towards the first portion 54.The aperture is offset from the outside curve of the stent graft so thatwhen it is positioned within the thoracic arch the aperture opensslightly to the ventral side of the arch. The great vessels, thebrachiocephalic, the left carotid and the left subclavian, branch fromthe thoracic arch and are slightly ventral with respect to the thoracicarch.

The recess 76 within the step portion 56 opens at its proximal end intotwo tubes 78 and 80. Each of the tubes may be of the same diameter orthe uppermost of the tubes 78 may have a diameter which is greater thanthe diameter of the lower tube 80. The tubes 78 and 80 extend towardsthe proximal end 61 of the stent graft 50.

Each of the smaller internal tubes 78 and 80 can be reinforced with ahelical shape memory wire reinforcement 83. Helical reinforcement forgraft material is shown in U.S. patent application Ser. No. 12/261,860entitled “Flexible Stent Graft” and the teachings therein areincorporated herein in their entirety.

FIG. 8 shows a schematic view of the placement of a stent graftaccording to one embodiment of the present invention into the thoracicarch of a patient.

The thoracic arch shown schematically comprises an ascending aorta 90extending to the thoracic arch 92 and a descending aorta 94 from thethoracic arch. Substantially at the top of the thoracic arch butslightly to the ventral side of the arch the major vessels branch offthe arch. The major vessels are the brachiocephalic artery 96, thecommon or left carotid artery 98 and the left subclavian 100. In apreparatory operation an anastomosis 102 is provided between the commoncarotid artery 98 and the left subclavian 100. The anastomosis providesaccess between the common carotid artery 98 and the left subclavianartery 100 which enables endovascular access to the stent graft viabrachial arteries in the left arm rather than endovascular access viathe left carotid artery which may be more complex.

The stent graft 106 is deployed into the thoracic arch such that thestep portion 108 is just proximal of the junction of the aorta with thebrachiocephalic artery 96. This means that there is defined between thestep portion, the upper wall of the thoracic arch and the second portionof the stent graft 109, an open region 111 so that circulation can bepreserved to the major vessels through the internal tubes 78 and 80 andthe recess 76 (see FIGS. 6 and 7) during the operation of deployment ofthe stent graft and subsequent placement of side branch grafts. Thespace also assists in enabling catheterisation of the internal tubes. Acatheter can be inserted as shown by the dotted line 110 to enter thelarger of the tubes 78 to enable placement of a side branch stent graft114 for the brachiocephalic artery 96 and a catheter can be inserted asshown by the dotted line 112 to enter the smaller of the tubes 80 toenable placement of a side branch stent graft 116 for the common carotidartery 98 and the left subclavian artery 100.

Because the space 111 provides maintenance of circulation to the majorvessels there may be circumstances where an operation can be carried outin stages.

In a preferred embodiment the larger of the internal tubes 78 has adiameter of 12 mm and the smaller of the tubes has a diameter of 10 mm.

Many modifications and other embodiments of the invention will come tothe mind of one skilled in the art having the benefit of the teachingspresented in the foregoing descriptions and associated drawings.Therefore, it is understood that the invention is not to be limited tothe specific embodiments disclosed, and that modifications andembodiments are intended to be included within the scope of the appendedclaims.

The invention claimed is:
 1. A method for placement of a medical devicein a patient, the method comprising: delivering a stent graft into amain vessel, the stent graft comprising at least one aperture in a graftsidewall, wherein the aperture opens into a recess, wherein the recesscomprises a volume of space bounded by the aperture in the graftsidewall and openings of at least two tubes which extend towards an endof the stent graft; delivering a first side branch stent graft throughthe aperture and into engagement with a first tube of the at least twotubes; and delivering a second side branch stent graft through theaperture and into engagement with a second tube of the at least twotubes.
 2. The method of claim 1, wherein the at least two tubes opendirectly into communication with a main lumen of the stent graft.
 3. Themethod of claim 1, wherein the stent graft comprises a first tubularbody portion, a second tubular body portion, and a main lumen extendingfrom the first tubular body portion to the second tubular body portion,the second tubular body portion having a smaller diameter than the firsttubular body portion.
 4. The method of claim 3, wherein a larger of theat least two tubes is adjacent a wall of the first tubular body portion.5. The method of claim 1, wherein when the stent graft is in a curvedstate, the at least one aperture is located on or adjacent the outsideof the curve.
 6. The method of claim 1, wherein the at least two tubeseach have a diameter in the range of from 6 to 12 mm.
 7. The method ofclaim 1, wherein the first tube has a diameter in the range of from 6 to10 mm and the second tube has a diameter in the range of from 8 to 12mm.
 8. The method of claim 1, wherein ends of the at least two tubes arejoined to each other.
 9. A method for placement of a medical device in apatient, the method comprising: delivering a stent graft into a mainvessel, the stent graft comprising a first tubular body portion, asecond tubular body portion, and a main lumen extending from the firsttubular body portion to the second tubular body portion, the secondtubular body portion having a smaller diameter than the first tubularbody portion, and at least one aperture in a graft sidewall, wherein theaperture opens into a recess, wherein the recess comprises a volume ofspace bounded by the aperture in the graft sidewall and openings of atleast two tubes which extend towards an end of the stent graft;delivering a first side branch stent graft through the aperture and intoengagement with a first tube of the at least two tubes; and delivering asecond side branch stent graft through the aperture and into engagementwith a second tube of the at least two tubes.
 10. The method of claim 9,wherein the at least two tubes open directly into communication with themain lumen of the stent graft.
 11. The method of claim 9, wherein alarger of the at least two tubes is adjacent a wall of the first tubularbody portion.
 12. The method of claim 9, wherein when the stent graft isin a curved state, the at least one aperture is located on or adjacentthe outside of the curve.
 13. The method of claim 9, wherein the atleast two tubes each have a diameter in the range of from 6 to 12 mm.14. The method of claim 9, wherein the first tube has a diameter in therange of from 6 to 10 mm and the second tube has a diameter in the rangeof from 8 to 12 mm.
 15. The method of claim 9, wherein ends of the atleast two tubes are joined to each other.